Registration Dossier
Registration Dossier
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EC number: 250-001-7 | CAS number: 30007-47-7
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Method: Patch test
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-bromo-5-nitro-1,3-dioxane
- EC Number:
- 250-001-7
- EC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Cas Number:
- 30007-47-7
- Molecular formula:
- C4H6BrNO4
- IUPAC Name:
- 5-bromo-5-nitro-1,3-dioxane
Constituent 1
Method
- Type of population:
- other: dermatitis patients
- Ethical approval:
- not specified
- Subjects:
- a) With ethanol
Patients: 1024
- Preparation: Test solution was prepared fresh every week
b) with petrolatum
Patients: 1085 - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
Range finding study: For detection of contact allergy to a preservative commonly higher concentrations than use concentrations have to be tested. Initially, test substance 1 % in ethanol was tested, but morphologically irritant reactions were noted in some patients. Therefore, the test concentration was lowered to 0.25 %.
ADMINISTRATION
- Type of application: occlusive
- Description of patch: The patch test was performed with the Al test technique (Astra Agency, Södertälje, Sweden).
The Al test was attached to Scanpore tape and the patches were removed from the back after two days.
- Vehicle / solvent: a) ethanol, b) petrolatum
- Concentrations: 0.25%
- Volume applied: 25 µL
- Removal of test substance: After two days
- Testing/scoring schedule: The tests were read one or, occasionally, two days after the removal.
EXAMINATIONS
- Grading/Scoring system: According to ICDRG criteria
- Statistical analysis: Fisher's exact test was used.
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions:
Ethanol: 17/1024 (1.7 %)
Petrolatum: 4/1085 (0.4 %)
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
